CN103237505A - An applier and a method for anchoring a lining to a hollow organ - Google Patents

An applier and a method for anchoring a lining to a hollow organ Download PDF

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Publication number
CN103237505A
CN103237505A CN2010800704423A CN201080070442A CN103237505A CN 103237505 A CN103237505 A CN 103237505A CN 2010800704423 A CN2010800704423 A CN 2010800704423A CN 201080070442 A CN201080070442 A CN 201080070442A CN 103237505 A CN103237505 A CN 103237505A
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CN
China
Prior art keywords
liner
applicator
clamping surface
intracavity
hollow organ
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Granted
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CN2010800704423A
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Chinese (zh)
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CN103237505B (en
Inventor
M·达坎格洛
J·哈里斯
E·安东
M·A·默里
F·比洛蒂
A·帕斯托里尔利
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Ethicon Endo Surgery Inc
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0076Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis in a single operation
    • A61B17/1155Circular staplers comprising a plurality of staples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3468Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07257Stapler heads characterised by its anvil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2901Details of shaft
    • A61B2017/2905Details of shaft flexible
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/30Surgical pincettes without pivotal connections
    • A61B2017/306Surgical pincettes without pivotal connections holding by means of suction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0089Instruments for placement or removal

Abstract

An endoluminal applier (1) for anchoring a tubular lining(9) to a hollow organ (10), the applier (1) comprising a staple fastening assembly (2) for clamping and stapling a ring shaped tissue portion between first and second clamping surfaces (5, 7),the staple fastening assembly (2)comprising a lining seat (8) adapted to receive the tubular lining(9) such that an elongate body portion (11) of the lining is held in a compacted ring shaped configuration and a ring shaped anchoring portion (12) of the lining(9) is held to overlap one of said first and second clamping surfaces (5, 7) and an annular row of staples (4).

Description

Liner is anchored to hollow organ's applicator and method
The specific embodiment
The specific embodiment
Referring to accompanying drawing, the wherein similarly similar anatomical structure of digitized representation and assembly in a plurality of views, Fig. 1 shows for tubulose liner 9 is anchored to the part that hollow organ 10(is anchored to patient's gastrointestinal tract particularly) intracavity applicator 1.Applicator 1 comprises the staple fastening assembly 2 with bin device 3, and described bin device holds the circular row of the seam nail 4 of at least one sealing, and its distal surface limits first clamping surface 5.Staple fastening assembly 2 also comprises anvil block 6, and it forms seam nail profiled surface and towards second clamping surface 7 of first clamping surface 5.Anvil block 6 can move with respect to bin device 3, and can cooperate with bin device 3, to follow closely 4 end for the annular tissue part and the formation that clamp between first clamping surface 5 and second clamping surface 7 from the seam that bin device 3 withdraws from.
Seam nail 4 can comprise the titanium seam nail in the tissue ring that is intended to for good and all to keep to be anchored at stitching, but or is used for bypass cannula temporarily is anchored at hollow organ's time-dependent biodegradable or the seam nail of bio-absorbable.
Staple fastening assembly 2 comprises ring liner seat 8, described ring liner seat can hold tubulose liner 9, make the elongated body portion 11 of liner be retained as with respect to the liner longitudinal extension to collapse (annular basically) configuration, as the annular anchorage part 12 of reeling, folding, compressing or rolling configuration and liner 9 be held with as described in one of first clamping surface 5 and second clamping surface 7 with as described in seam to follow closely 4 circular row overlapping.
This relative localization of having guaranteed liner 9 anchorage parts 12, delegation's seam nail 4 and clamping surface 5,7 is correct.In addition, liner 9 is positioned at external carrying out on gasket base 8, and intracavity insert in the process of applicator 1 and process in the percussion of seam nail 4 in can not change.
According to an embodiment, gasket base 8 forms in anvil block 6 and comprises distally surrounding blocking wall 29(Figure 13), collapse and the tubulose liner 9(of " accumulation " intracavity sleeve pipe for example) be resisted against on the described surrounding blocking wall, make that described liner keeps collapsing and " accumulation " shape, cross surrounding blocking wall 29 distad tractive or promotion up to liner 9, perhaps (for example in the process that anvil block 6 takes out from by the sleeve pipe 9 of anchoring) surrounding blocking wall 29 is bent downwardly by external force or disconnects.
According to an embodiment, gasket base 8 can make that in the process of staple fastening assembly 2 closures at least a portion of the main part 11 of liner 9 is crossed surrounding blocking wall 29 and is forced to distad promote, and releases gasket base 8.
In addition, gasket base 8 can comprise clamped edge 30, described clamped edge is disposed near second clamping surface 7 of anvil block 6 and anchorage part 12 can be remained on its tram, up to (for example in the process that anvil block 6 takes out from by the sleeve pipe 9 of anchoring) its by external force from clamped edge 30 taking-ups.
According to an embodiment, clamped edge is flexiblely supported or is setovered by magnetic force, in order to keep anchorage part 12 with resiliencely, and makes it relatively easily take out afterwards.Alternatively, clamped edge 30 can comprise plate, and described plate can be threaded onto in the anvil block 6 anchorage part 12 with gripping sleeve 9, and holds it in the tram.
According to another embodiment, staple fastening assembly 2 comprises cutter sweep, for example can be with the anchorage part 12 of liner from gasket base 8, particularly from the circular cutting plate (not shown) of clamped edge 30 excisions.
Advantageously, cutter sweep is arranged to and can operates for apart from the certain distance of the grip tissue position of second clamping surface, 7 distally (for example) cutting anchorage part 12.
Staple fastening assembly 2 form longitudinal extensions pass bin device 3 and pass anvil block 6, side direction feeds the central passage 13 of the clamping space 14 between first clamping surface 5 and second clamping surface 7 then.Thereby central passage 13 is suitable for endoscope 15 by observing the space in clamping space 14 and distally, staple fastening assembly 2 the place ahead, and if possible, be used for making whole applicator 1 or at least staple fastening assembly 2 slide into hollow organ 10 target site at intracavity along endoscope 15, be used for intracavity by means of endoscope 15 with whole applicator 1 or at least staple fastening assembly 2 be directed to described target site.
Gou Zao applicator 1 makes and inserts and take out in the process of applicator 1 and be improved by gastrointestinal guiding and the continuous observation undertaken by the endoscope 15 that is contained in the central passage 13 in the process of anchoring tubulose liner 9 at fastening seam nail 4 at intracavity like this.
According to embodiment, endoscope 15 can be flexible standard endoscope or the assembly of applicator 1, if the latter, then it especially can cooperate the assembly of the central passage 13 of this applicator, and it is except being used for observation and guiding, also be used for carrying out other functions of applicator, example is tissue sampling as will be described further below.
According to an embodiment, staple fastening assembly 2 is arranged on far-end 16 places of flexible hollow axle 17, central passage 13 is passed described flexible hollow axle 17 proximads and is extended to its proximal aperture (not shown), and described flexible hollow axle 17 can be inserted in the endoscope 15 fully.
Alternatively, have only the staple fastening assembly 2 of applicator 1 can hold endoscope 15 in the central passage 13, and be directed to target site being used for anchoring liner 9 by endoscope 15, and flexible shaft 17 can extend laterally from the axle of endoscope 15.Yet, have the bin device 3 of first clamping surface 5 and have the complete closed endless belt that the anvil block 6 of second clamping surface 7 limits around central passage 13, make and can obtain continuous circular shape seam nail line by single clamp tissue and seam nail percussion step.
According to an embodiment, anvil block 6 is by at least one, relative anvil shaft 25 can be connected to translation bin device 3 on preferred two diameters, described anvil shaft 25 can be slidingly received in one or more pilot holes 28 of bin device 3, and is connected with the motion that can make anvil block 6 with respect to bin device 3 motions.Pilot hole 28 and anvil shaft 25 are disposed in central passage 13 and stitch in the zone of following closely between the row, be the inner radial of the radially outer of central passage 13 and annulus nail row, thereby make and in anvil block approaches and clamp the process of the tissue of gathering, can carry out also completely that endoscope enters and observes.Anvil shaft 25 can have very limited circumferential extension, thereby does not hinder the observation to clamp tissue space 14.
Anvil shaft 25 preferably includes the tubular shape of hollow, this profile has high moment of torsion resistance for given external dimensions, and they with respect to total circumferential extension of the longitudinal axis of applicator 1 less than 100 °, preferably less than 60 ° even be more preferably less than 45 °, in order between axle 25, reserve enough unobstructed spaces, make and observe and enter clamping space 14 like a cork from central passage 13.
According to an embodiment, applicator 1 comprises tissue sampling mechanism 18, and the tissue part 19 of annular basically of the hollow organ 10 in the clamping space 14 between first clamping surface 5 and second clamping surface 7 can be gathered by described tissue sampling mechanism.Central passage 13 and delegation's seam that tissue sampling mechanism 18 can be disposed in the staple fastening assembly 2 are followed closely between 4, i.e. the inner radial of the circular row of the radially outer of central passage 13 and seam nail 4.Like this, central passage 13 is not organized collecting mechanism 18 and stops, and also allows to be undertaken unobstructedly entering and observing by endoscope 15 in the process of tissue sampling.Alternatively, for example be contained in the central passage 13 of staple fastening assembly 2 by 20 while of the instrument channel endoscope 15 that makes tissue sampling mechanism 18 pass endoscope 15, tissue sampling mechanism 18 and endoscope 15 can be together and are contained in simultaneously in the central passage 13.According to embodiment, tissue sampling mechanism 18 can comprise mechanical grasper or aspirator.
Fig. 7 shows exemplary embodiment, wherein at least one pair of, preferred many grasper 21 are arranged to and can operate for radially outward moving from clamping space 14 and the relative part of hollow organ 10 tissue promptly, and for example by at bin device 3 interior sections or fully take out grasper 21 and part that the quilt that will organize is grabbed into is pulled in the clamping space 14.Grasper 21 can activate the motion emitters by one or more collections and be connected with near the external collection activation mechanism that for example provides the proximal part of the nearside shank place of applicator 1 or endoscope 15.
Grasper 21 can with staple fastening assembly 2, particularly with the zone of the inner radial of the circular row of the radially outer of central passage 13 and seam nail 4 in bin device 3 directly or indirectly be connected; Alternatively, for example by grasper 21 is contained in the central passage 13 of staple fastening assembly 2 by 20 while of the instrument channel endoscope 15 of endoscope 15, grasper 21 and endoscope 15 can be together and are contained in simultaneously in the central passage 13.In these two embodiment, be guaranteed by the tissue sampling in the endoscopic observation clamping space, and be unobstructed.
According to other exemplary embodiment (Figure 13 to 17), tissue sampling mechanism 18 comprises one or more suction socket 22,23,24 that are preferably external suction pump that are connected to. Suction socket 22,23,24 are arranged to and can operate for applying vacuum or suction at clamping space 14, remain between first clamping surface 5 and second clamping surface 7 with the tissue around gathering and with described suction socket.
Suction socket 22,23 can form in the annular region in first clamping surface 5 of bin device 3, and described annular region is extended between the circular row of central passage 13 and seam nail 4.In addition, suction socket 23 also can form in the zone of one or more anvil shaft 25.(Figure 17) in this case, more than first suction socket 22 can be to extend between the anvil shaft 25 and form in the zone of the inner radial of delegation's seam nail 4, and more than second suction socket 23 is anvil shaft 25 and forms in the zone between delegation's seam nail 4 on every side.
Suction socket 22,23 also can form in the radially-outer surface of annular suction walls 26, and described annular suction walls 26 is arranged on the clamping space 14 of the inner radial that is arranged in central passage 13 radially outers and delegation's seam nail 4.Suction walls 26 can be slidingly received in the annular seating in the bin device, and can move to active position from resting position, in resting position, suction walls 26 bounces back at the inside of bin device 3 proximad, in active position, suction walls 26 distad stretches (referring to the arrow 27 in Figure 13 and 15) towards anvil block 6.
According to an embodiment, the motion of suction walls 26 between resting position and active position can be relevant and move according to this motion with respect to the motion of bin device 3 with anvil block 6.For example, when opening staple fastening assembly 2, the anvil block distal motion is away from bin device 3, and suction walls 26 moves to its active position; And when closing staple fastening assembly 2, anvil block 6 is towards bin device 3 proximal motion, and suction walls 26 bounces back to its resting position.
Suction walls can form by extending radially outwardly from one or more anvil shaft 25 and following closely 4 ring walls that extend radially inwardly from delegation's seam, or forms by one or more arcuate wall parts of for example only extending in the perimeter of one or more anvil shaft 25.Also imagined more than the 3rd the suction socket 24(Figure 15,16 that can in the radially-outer surface of one or more anvil shaft 25, form).In this case, a part that forms one or more anvil shaft 25 of suction socket 24 can form the part of suction walls 26, and can be connected to suction walls 26, makes them move together.
Must be noted that when suction walls 26 moves to active position, between second clamping surface 7 of the far-end of suction walls 26 and anvil block 6, reserve free unobstructed space, thereby guarantee that clamping space 14 is visual at least in part.
According to exemplary embodiment (Figure 18 and 19), tubulose liner 9 or sleeve pipe are by means of the wrappage 31(that can remove for example housing or baling line) and be retained as the collapsing or " accumulation " configuration of annular basically of described liner.What wrappage 31 had that the special use that can be connected to applicator 1, preferably can be connected to gasket base 8 divests fastener divests part 32, make when being removed applicator 1 by the liner 9 of anchoring, divesting part 32 is pulled out, and remove (Figure 19) with wrappage 31 destructions or with it from liner 9, described liner is released at this moment with extending longitudinally.For this purpose, the distally tube ends can be provided with one or more intensive pieces 34, for example becket or ball, and it is conducive to sleeve pipe along gastrointestinal plan part longitudinal extension.
According to an embodiment, the anchorage part 12 of tubulose liner 9 comprises rigidity or semirigid connector board, and it can be connected to gasket base 8 by snap fit or interference fit.Connector board can be broken into fragment in the process of sewing up, in order to allow anvil block to take out at nearside by the annular anchoring site of sewing up.
Though the applicator embodiment shown in the figure has an independent sealing row of seam nail groove and seam nail, applicator 1 can be provided with the multirow cannelure that holds multirow seam nail 4.
The liner 9 that is intended to form the intracavity bypass duct can be formed by the graft materials of any suitable biocompatibility, for example polyester or PTFE, rubber, polytetrafluoroethylene, nylon, terylene, polyethylene, polystyrene, polyurethane, polyethylene terephthalate etc.According to another embodiment, but liner 9 and seam nail 4 both all can be bio-absorbable, and passing that can be in time and dissolving fully.
Mentioned as mentioned, applicator 1 comprises anvil block motion and seam nail driving mechanism, described anvil block motion is connected with the motion-activated mechanism of external anvil block that for example provides at the nearside shank place of applicator 1 by the anvil block motion emitter of one or more flexibilities, and described seam nail driving mechanism can drive seam nail 4 and distad shift out on the seam nail profiled surface that stitches the nail groove and be resisted against anvil block.
In addition, seam nail driving mechanism is connected with the external seam nail firing lock that for example provides at the nearside shank place of applicator 1 by one or more soft drive motion emitters.Anvil block motion emitter and actuation movement emitter all are disposed in the inside of flexible shaft 17.
Figure 20 shows the exemplary embodiment of applicator, wherein the second clamping surface 7(of first clamping surface 5 of bin device and anvil block 6 its seam nail profiled surface is provided) have a common wave-like, described wave-like preferably but not necessarily constituted with two relative paddy 36 by two relative peaks 35, described peak and paddy open and form two peaks, two paddy type waves with about 90 ° angle intervals.The wave-like of clamping surface 5,7 can by local stairstepping or in other words offset configuration (this configuration is with the shape " vibration " of approximate wave) obtain.Particularly, stairstepping first clamping surface 5 is made up of a series of platforms 37 and riser 38, and wherein platform 37 is perpendicular to the longitudinal axis X of staple fastening assembly 2, and the opening that withdraws from of the groove of seam nail 4 is limited in the platform 37.Similarly, second clamping surface 7 of anvil block also is made up of a series of platforms 39 and riser 40, and wherein platform 39 is perpendicular to the longitudinal axis X of staple fastening assembly 2, and the seam staple forming pockets is limited in the platform 39.
Among both, platform 37,39 limits obtuse angles with riser 38,40, in order to reduce the local organization tension in the process that clamps and sew up at first clamping surface 5 and second clamping surface 7.
All seam nail gathering sills all can extend along the normal direction that is roughly corresponding platform 37 and the direction parallel with respect to longitudinal axis X.
Therefore, all seam nails 4 that are contained in the gathering sill can be with respect to the seam nail driving direction parallel aligned of seam nail driving mechanism, and therefore described seam nail driving mechanism can overlap with longitudinal axis X.
In order to limit the diameter of staple fastening assembly, clamping surface 5,7 described wave and stairstepping shape depart from the circular reference figuration of hypothesis in the plane perpendicular to longitudinal axis X, described longitudinal axis is only along the direction perpendicular to this plane so that the projection of first clamping surface 5 and second clamping surface 7 and at least delegation's seam nail 4 toroids that limit on this plane for circular.
In this embodiment, the annular anchorage part 12 of liner 9 can be held overlapping with the circular row of one of first clamping surface 5 and second clamping surface 7 and seam nail 4 by same structure and the method for describing in conjunction with the embodiment of Fig. 1 to 19 before this.In addition or alternatively, anchorage part 12 can be fixed to wavy or stairstepping wave shape clamping surface by binding agent separably, make anchorage part keep wave-like or the stairstepping wave-like identical with clamping surface.
According to an embodiment, annular anchorage part 12 can have wave-like or the stairstepping wave-like with the shape complementarity of clamping surface, and can flexiblely be deformed into even shape, wherein be in the access portal of the anchorage part 12 in the even shape greater than the access portal that is in the anchorage part in the wave-like.
This make applicator 1 can be more cosily from anchoring site retraction, and can take out anvil block by tissue ring and the anchorage part of sewing up, described anchorage part this moment can circumferentially extending (being stretched to even shape from wave-like) and itself otherwise have rigidity slightly.In addition, the anchoring site of the tubulose liner physiology that can follow intestinal in the process as the wriggling of intestinal in certain limit expands and retraction and moving.
The tubulose liner is anchored at the specific embodiment of the method in the hollow organ
Can comprise that patient's body and spirit are evaluated at interior clinical work-up, to determine whether have clinical indication through the anchoring of pars oralis pharyngis administration and intracavity sleeve pipe.This assessment can comprise the esophagus stomach function regulating that checks the patient, to determine whether carry out this operation exists any contraindication, for example ulcer, block other diseases that maybe may hinder treatment.In case assessment is finished, be the patient who in operating room, faces general anesthesia, be in the face of being in the patient of sedation in Endoscopy Room, the operator can prepare applicator 1, wherein the tubulose liner 9 with compactness is placed on (as shown in Figure 1) on the gasket base 8, and applicator 1 is slided in endoscope 15, under endoscopic observation, its esophagus stomach function regulating along the patient is directed to the target position of (for example, in the duodenum) in the gastrointestinal tract downwards.In case in place, the internist just uses the endoscope 15 in the central passage 13 that is placed on applicator 1 to observe and select to be suitable for to apply the zone of securing member (that is seam nail).
Fig. 3 to 8 shows following method step and the effect of applicator in the target part of intestinal.
In case applicator 1 is positioned in the anatomical position of selection, just by making anvil block 6 distal motion open staple fastening assembly 2, so that clamping space 14 is exposed to ID surrounding tissue, and can activate the tissue sampling mechanism that vacuum or machinery are firmly grasped, and mode that can be circumferential fully or basically circumferential mode (that is, some with respect to the longitudinal axis of applicator less than the some places of 360 degree at least in part around the girth of applicator) will organize 19 to be pulled in the clamping space 14.
Because central passage 13 is led to clamping space 14, therefore whole tissue sampling step can directly be passed through endoscopic observation.
After the tissue 19 with aequum collects in the clamping space 14, can make the tissue ring of gathering 19 between anvil block and bin device, clamp anvil block 6 and the motion each other of bin device 3 courts.Then, activate the seam nail driving mechanism of applicator 1, the tissue ring of being gathered to pass through 19 and the described anchorage part of anchorage part 12(by liner 9 are disposed on the anvil block, to cover second clamping surface and seam nail position) closing seam nail row or the tightening member of engagement annular, thus in circumferential mode that liner 9 is fastening in place.Subsequently, annular anchorage point can directly be used endoscopic observation by making endoscope 15 distad pass anvil block 3.Then, remove applicator 1.In this case, can be carefully with anvil block 6 tractives of applicator 1 by the newborn ring formation of suture tissue 19 or the anchorage part 12 of folding folds in a garment and liner 9, thereby make still compact liner 9 in place.In the process of sewing up, liner can be released from the gasket base of anvil block; Or in the process of taking out applicator, anvil block can be pulled away from by the liner of anchoring.In addition, the percussion applicator or with applicator when being fetched by the liner of anchoring, can destroy making liner keep the wrappage 31 of compact form or it is removed from liner, thereby make liner along hollow organ's plan part extending longitudinally, shown in Fig. 9 and 10.Like this, just generated and food directly can have been led the target position of small intestinal to realize the bypass duct of malabsorption effect from anchorage point, under the situation that this malabsorption effect occurs, this type of effect can strengthen lose weight effect and the initial described effect that in the ordinary course of things hormone signal is sent.
Particularly, described method and apparatus helps to simulate gastric bypass is curing type 2 diabetes mellitus and is promoting effect in the process that loses weight, helps to improve glycemic control and reduces or eliminates other comorbiditieses of serious obesity.In addition, described method and apparatus can advantageously use in conjunction with the other treatment scheme that is used for the treatment of type 2 diabetes mellitus and comorbidities thereof, and removes the patient to the fear of intrusive mood operation.Last but it is also important that described method and apparatus allows to carry out reversible operation, in case required effect is achieved, intracavity liner or sleeve pipe just can relatively easily be removed or be removed certainly (passing through biodegradation).
Although described the preferred embodiments of the present invention in detail, applicant's purpose is not that the scope with claim is limited to these specific embodiments, changes and alternate configuration but cover the institute that drops in the scope of the invention.
Technical field
The present invention relates generally to armarium and method, and relate more specifically to liner is located and is anchored to the apparatus and method of hollow body organ (for example stomach, intestinal or gastrointestinal tract).
Background technology
With regard to serious obesity, the patient can experience polytype surgical operation at present, with ligation or sew up large intestine or the part of small intestinal or stomach, and/or detours and mistake from the part of these organs, thereby reduce the required quantity of food of patient, and the amount that absorbs of gastrointestinal tract.Available operation at present comprises peritoneoscope band art (device was used for " ligation " or tightened the part of stomach this moment), perpendicular fasciculus belt gastroplasty (VBG) or is called as the invasive surgical operation of having more of Roux-En-Y gastric bypass, and these operations are used for realizing that permanent operations of stomach subtract holds and follow-up intestinal bypass.
These stomach volume reduction surgeries make the size of patient's stomach reduce, they lack food thereby force its health requirement, cause weight in patients to alleviate thus, but because there is invasive in operation, therefore there is multiple restriction in these operations, comprise other complication that time, general anesthesia, wound healing and major operation are followed.In addition, because there is complication (comprising mortality risk) in these operations, therefore it only can be used for serious fat patient's (morbid obesity, body-mass index 〉=40), thereby only for having stayed (if any) seldom, the patient who is regarded as general obesity or moderate obesity gets involved the space of selecting.
Except above-mentioned gastrointestinal volume reduction surgery, the known intracavity sleeve pipe that uses comes partially or completely some part lining as the harmonization of the stomach intestinal, in order to separate from least a portion of the food stream of gastrointestinal tract lining part or it is detoured.According to observations, by between some zone of dietary intake and gastrointestinal wall, setting up physical barriers by the intracavity sleeve pipe, can realize and losing weight and improving or cure the similar beneficial effect of effect aspect the type 2 diabetes mellitus by what carry out that gastric bypass obtains.The internist thinks, by set up physical barriers between institute's favored area of dietary intake and gastrointestinal wall, can on purpose influence the hormone signal activation mechanism that is derived from intestinal.
The intracavity sleeve pipe of known type relies on expandable metal structure (for example support) and engages hollow organ on every side, thereby sleeve pipe is remained on the plan position.For anchoring and the stability of improving sleeve pipe, it is also known that provides the support with barb, described barb to penetrate tissue on every side.
However, observe the endoscope type sleeve pipe and tended at the gastrointestinal tract internal motion, and moved away from their original plan position.
Authorize people's such as Gannoe U.S. Patent No. 7,220,237B2 " Method and device for use in endoscopic organ procedures " (method and apparatus that is used for the endoscope type organ surgery) has described the operation of a gastrointestinal part being carried out inner lining, this operation uses tubular cavity inner sleeve and stapling apparatus circumferentially to gather the tissue of coat of the stomach and the circular portion of the tissue gathered is fixed, and wherein the intracavity sleeve pipe is got involved by shape and is fixed to this circular portion.
Yet, the intracavity liner is placed and is fixed on the known method of (especially in the gastrointestinal tract) in the hollow organ and device in the anchoring and be retained in aspect the plan position still not ideal reliably of intracavity sleeve pipe.
In addition, known devices and method are failed fully to satisfy the correct target site that is used for anchoring intracavity sleeve pipe are carried out good vision control and the needs of confirming.
In addition, known devices and method are failed fully to satisfy and are set up the sealing between intracavity sleeve pipe and the hollow organ or be tightly connected the needs of zone with the required mobility program of acquisition food stream and body fluid flow (for example gastric juice, bile and pancreatic juice).
In addition, known devices and method fail fully to satisfy in the demand and the particular problem that remove, replace or produce under the situation of placing chamber inner sleeve again.
Therefore, the intracavity sleeve pipe need be located and is anchored at device and the operation of the improvement in the gastrointestinal tract.
Summary of the invention
The invention provides the intracavity liner through oropharynx or through endoscope location and be anchored at hollow body organ (particularly, gastrointestinal tract) equipment of Nei improvement and method, unless otherwise, otherwise described hollow body organ includes but not limited to the part of esophagus, stomach, intestinal or whole length etc.For the present invention, surgeon or endoscope's user can insert device as described below by patient's oral cavity, insert stomach or intestinal downwards then according to circumstances along esophagus.Operation can be carried out from patient's stomach or the inside of other intestinals fully, might not need any external undercut.
At least a portion of top definite demand satisfies by the method that the tubulose liner is applied to hollow organ's (being applied to the gastrointestinal inner chamber particularly), described method comprises: the tubulose liner is attached to applicator, make the elongated body portion of liner be retained as (annular basically) configuration of collapsing with respect to the longitudinal extension of liner, be held overlapping with at least one securing member of applicator as the annular anchorage part of reeling, folding, compressing or rolling configuration and liner; The applicator that will have attached tubulose liner, securing member and endoscope is placed into interior intracavity at intracavity; Use endoscopic observation to be suitable for applying the zone of securing member; Enter internal chamber wall and securing member is applied to the appropriate area of inner chamber by the anchorage part that makes securing member extend through the tubulose liner, thereby the tubulose liner is attached to the appropriate area of inner chamber; And the attached tubulose liner of tractive distad, so that it is expanded into (basically elongated tubular form) configuration of extension by the configuration of collapsing.
According to an aspect of the present invention, internal chamber wall partly is inverted to generate the appropriate area be used to applying described at least one securing member, and if possible, securing member extends and to penetrate by partly being inverted at least two adjacent layers of the tissue that internal chamber wall arranges.
Described method is also included checks the step of described at least one attached securing member under the sight glass.
According to another aspect of the present invention, over time, under endoscope, the tubulose liner is removed from inner chamber.
At least a portion of top definite demand also can satisfy by the intracavity applicator that is used for the tubulose liner is anchored to the hollow organ, described applicator comprises the staple fastening assembly with bin device and anvil block, described bin device holds the annulus nail row of at least one sealing and forms first clamping surface, and described anvil block forms seam nail profiled surface and towards second clamping surface of first clamping surface.Anvil block can move with respect to bin device, and can cooperate with bin device, be used for to clamp the annular tissue part between first clamping surface and second clamping surface and to form the end of the seam nail that withdraws from from bin device.
Staple fastening assembly comprises the ring liner seat, described ring liner seat can hold the tubulose liner, make the elongated body portion of liner be retained as with respect to the liner longitudinal extension to collapse (annular basically) configuration, as the annular anchorage part of reeling, folding, compressing or rolling configuration and liner be held with as described in one of clamping surface with as described in the annulus nail capable overlapping.
This relative localization of having guaranteed liner anchorage part, delegation's seam nail and clamping surface is correct.In addition, liner is positioned at external carrying out on gasket base, and inserts in the process of applicator and in the process of sewing up at intracavity and can not change.
According to an aspect of the present invention, staple fastening assembly form longitudinal extension pass bin device and pass anvil block, side direction feeds the central passage in the space between first clamping surface and second clamping surface then, described central passage is suitable for endoscope by to observe space between first clamping surface and second clamping surface and the space in distally, staple fastening assembly the place ahead, and if possible, be used for making applicator slide into hollow organ's target site along described endoscope at intracavity.
Applicator makes the continuous observation that guides by gastrointestinal in the process of intracavity insertion and taking-up applicator and in the process of fastening seam nail and undertaken by the endoscope that is contained in the central passage be improved.
According to another aspect of the present invention, applicator comprises tissue sampling mechanism, and the tissue part of annular basically of the hollow organ in the space between first clamp tissue surface and the second clamp tissue surface can be gathered by described tissue sampling mechanism.Tissue sampling mechanism can be disposed in the staple fastening assembly, between central passage and seam nail row, i.e. and the inner radial of the radially outer of central passage and annulus nail row, thus make and can carry out also in the process of tissue sampling completely that vision enters.Alternatively, for example by tissue sampling mechanism is contained in the central passage of staple fastening assembly by the instrument channel while endoscope of endoscope, tissue sampling mechanism and endoscope can be contained in the central passage together and simultaneously.Tissue sampling mechanism can comprise mechanical grasper or aspirator.
According to an aspect of the present invention, anvil block is by at least one, relative anvil shaft can be connected to translation bin device on preferred two diameters, described anvil shaft can be slidingly received in one or more pilot holes of bin device, and is connected with the motion that can make anvil block with respect to the bin device motion.Pilot hole and anvil shaft are disposed in central passage and stitch in the annular region of following closely between the row, be the inner radial of the radially outer of central passage and annulus nail row, thereby make and in anvil block approaches and clamp the process of the tissue of gathering, can carry out also completely that vision enters.Anvil shaft can have very limited circumferential extension, thereby does not hinder the observation to the clamp tissue space.
By accompanying drawing and explanation thereof, these and other aspects of the present invention and advantage will become obvious, described accompanying drawing and explanation thereof show embodiments of the invention, and are used for explaining principle of the present invention together with the specific embodiment of the whole embodiment that describes and hereinafter provide of the present invention that provides above.
Description of drawings
-Fig. 1 shows for the intracavity applicator that is in closed configuration that the tubulose liner is anchored to the hollow organ;
-Fig. 2 shows the applicator that is in the Fig. 1 in the open configuration;
-Fig. 3 shows the applicator of Fig. 1 is introduced duodenum through oropharynx;
-Fig. 4 is the close-up view that is in the applicator in the closed configuration at interior intracavity;
-Fig. 5 shows the method step that opens it behind the target position that applicator is positioned in the gastrointestinal tract;
-Fig. 6 is the close-up view that is in the applicator in the open configuration at interior intracavity;
-Fig. 7 shows particularly suitable applicator and the method for the tissue of gathering the hollow organ, and wherein the tubulose liner is intended to be fastened to this hollow organ according to an embodiment;
The anchorage part that-Fig. 8 shows the tissue wherein gathered and liner is clamped in the applicator in the closed configuration of being between the anvil block of applicator and the bin device, and described applicator has been ready to apply securing member;
-Fig. 9 is anchored to hollow organ's target position but still is in the schematic cross sectional views of collapsing or piling up the tubulose liner in the shape;
Tubulose liner after-Figure 10 shows and extends fully in anchoring and in a gastrointestinal part;
-Figure 11 shows another embodiment of method, wherein the tubulose liner be applied in device be anchored at lower esophageal sphincter (LES) under, thereby produce from LES down to stomach-jejunum liner or the stomach liner of pylorus;
-Figure 12 shows different may locate of tubulose liner in patient's gastrointestinal tract;
-Figure 13 is the partial side view according to the applicator of another embodiment;
-Figure 14 is the sectional view of the plane X IV-XIV among Figure 13;
-Figure 15 is the partial side view according to the applicator of another embodiment;
-Figure 16 is the sectional view of the plane X VI-XVI among Figure 15;
-Figure 17 is the sectional view that illustrates according to the bin device far-end of the applicator of another embodiment;
-Figure 18 and 19 is the partial side views according to the applicator in the process of the method step of another embodiment;
-Figure 20 shows the applicator in the open configuration of being in according to another embodiment.

Claims (23)

1. intracavity applicator (1) that is used for tubulose liner (9) is anchored to hollow organ (10), described applicator (1) comprises having bin device (3), the staple fastening assembly (2) of anvil block (6), described bin device holds the seam of at least one sealing and follows closely the circular row of (4) and limit first clamping surface (5), described anvil block forms seam nail profiled surface and towards second clamping surface (7) of described first clamping surface (5), described anvil block (6) can cooperate with described bin device (3), to follow closely the end of (4) for the annular tissue part and the formation that clamp between described first clamping surface (5) and second clamping surface (7) from the described seam that described bin device (3) withdraws from
Wherein said staple fastening assembly (2) comprises gasket base (8), described gasket base can hold described tubulose liner (9), and it is overlapping that the annular anchorage part (12) that makes the elongated body portion (11) of described liner be retained as compact loop configurations and described liner (9) is held to follow closely with one of described first clamping surface (5) and second clamping surface (7) and described seam the circular row of (4).
2. according to the described intracavity applicator of aforementioned claim (1), wherein said staple fastening assembly (2) forms longitudinal extension and passes described bin device (3) and pass described anvil block (6), side direction feeds the central passage (13) of the clamping space (14) between described first clamping surface (5) and second clamping surface (7) then, described central passage (13) is suitable for endoscope (15) thereby by can observing the space in described clamping space (14) and described staple fastening assembly (2) distally, the place ahead, and is used for described staple fastening assembly (2) is slided along described endoscope (15) at intracavity.
3. according to each described intracavity applicator (1) in the aforementioned claim, wherein said anvil block (6) by two relative anvil shaft (25) translation be connected to described bin device (3), described anvil shaft is disposed in the zone of the radially outer of described central passage (13) and the inner radial that described annulus nail is gone, described anvil shaft (25) is reserved unobstructed space between the inner radial that radially outer and the described annulus nail of described central passage are gone, to enter for from described central passage (13) described clamping space (14) being observed with apparatus.
4. according to each described intracavity applicator (1) in the aforementioned claim, comprise the tissue sampling mechanism (18) of the described hollow organ's (10) that can gather in the described clamping space (14) the part of annular tissue basically (19).
5. intracavity applicator according to claim 4 (1), wherein be contained in the described central passage (13) by instrument channel (20) the described endoscope of while (15) that makes described tissue sampling mechanism (18) pass described endoscope (15), described tissue sampling mechanism (18) and described endoscope (15) can be contained in the described central passage (13) simultaneously.
6. intracavity applicator according to claim 4 (1), wherein said tissue sampling mechanism (18) is disposed in the inner radial of the circular row of the radially outer of described central passage (13) and described seam nail (4).
7. according to each described intracavity applicator (1) in the claim 4 to 6, wherein said tissue sampling mechanism (18) comprises at least one pair of grasper (21), described grasper can be operated the relative part of radially outward moving and firmly grasping described hollow organ's (10) tissue for from described clamping space (14), and the part that the quilt that will organize is firmly grasped is pulled in the described clamping space (14).
8. according to each described intracavity applicator (1) in the claim 4 to 6, wherein said tissue sampling mechanism (18) comprises and is connected to suction pump and is arranged to and can operates for the suction socket (22 that applies vacuum at described clamping space (14), 23,24).
9. according to each described intracavity applicator (1) in the claim 4 to 6, form in the annular region of wherein said suction socket (22,23) between the circular row of described central passage (13) and described seam nail (4).
10. according to each described intracavity applicator (1) in the claim 4 to 6, wherein said suction socket (22,23) form in the annular suction walls (26) in being arranged on described clamping space (14), described suction walls (26) can be slidingly received in the described bin device and can move between retraction resting position and stretching, extension active position with respect to the motion of described bin device (3) according to described anvil block (6).
11. according to each described intracavity applicator (1) in the aforementioned claim, wherein said gasket base (8) forms in described anvil block (6) and comprises distally surrounding blocking wall (29), the tubulose liner (9) of described compactness is resisted against on the described surrounding blocking wall, make described liner keep compact shape, cross described surrounding blocking wall (29) distal motion up to described liner (9).
12. intracavity applicator according to claim 11 (1), wherein said gasket base (8) can make that under the predetermined clossing pressure of described staple fastening assembly (2) at least a portion of the described main part (11) of described liner (9) is forced to distad release described gasket base (8).
13. according to each described intracavity applicator (1) in the aforementioned claim, wherein said gasket base (8) comprises clamped edge (30), described clamped edge is disposed near described second clamping surface (7) of described anvil block (6) and described anchorage part (12) can be remained on its tram, is removed from described clamped edge (30) by external force up to it.
14. intracavity applicator according to claim 13 (1) comprises the cutting plate that the described anchorage part (12) of described liner can be excised from described gasket base (8).
15. according to each described intracavity applicator (1) in the aforementioned claim, wherein said tubulose liner (9) keeps the compact configuration of annular of described liner by means of the wrappage that can remove (31), described wrappage has divest partly (32) that can be connected to described applicator (1), make that when being removed described applicator (1) by the liner of anchoring (9), the described part (32) that divests is pulled and described wrappage (31) is removed from described liner (9).
16. according to each described intracavity applicator (1) in the aforementioned claim, the described anchorage part (12) of wherein said tubulose liner (9) comprises rigidity or semirigid connector board, and described connector board can be connected to described gasket base (8) by snap fit or interference fit.
17. according to each described intracavity applicator (1) in the aforementioned claim, wherein said first clamping surface (5) and described second clamping surface (7) have whole wave-like (35,36).
18. intracavity applicator according to claim 17 (1), wherein said wave-like forms by the stairstepping configuration of described first clamping surface (5) and second clamping surface (7).
19. according to claim 17 or 18 described intracavity applicators (1), the described annular anchorage part (12) of wherein said tubulose liner (9) has and described clamping surface (5, the wave-like of described wave-like complementation 7), and can flexiblely be deformed into even shape, wherein be in the access portal of the described anchorage part (12) in the described even shape greater than the described access portal that is in the described anchorage part in the described wave-like.
20. one kind is applied to the hollow organ with the tubulose liner, is applied to the method for described gastrointestinal inner chamber particularly, comprising:
-described tubulose liner is attached to applicator, make the elongated body portion of described liner be retained as basically the compact and annular anchorage part described liner of annular and be held overlapping with at least one securing member of described applicator,
-the applicator that will have attached tubulose liner, described securing member and an endoscope is placed among the described hollow organ at intracavity,
The described endoscopic observation of-use is suitable for applying the zone of described securing member,
-enter described hollow organ's wall and described securing member is applied to described hollow organ's appropriate area by the described anchorage part that makes described securing member extend through described tubulose liner, thus described tubulose liner is attached to described appropriate area; And
-with attached tubulose liner along described hollow organ's tractive, its loop configurations from described compactness is expanded into the elongated tubular product such configuration of extension.
21. the method that the tubulose liner is applied to the hollow organ according to claim 20, comprise that the described wall part ground inversion with described hollow organ is used for applying the described appropriate area of described at least one securing member to generate, and make described securing member extend at least two adjacent layers of the inverted wall of part that penetrates described hollow organ.
22. described the tubulose liner is applied to hollow organ's method according to claim 20 or 21, checks the step of described at least one attached securing member under the sight glass that included.
23. according to claim 20 the tubulose liner is applied to hollow organ's method, wherein over time, under endoscope, described tubulose liner is removed from described hollow organ.
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